A medicine-food combination for assisting in regulating blood sugar, and its preparation method, application, and preparation

Abstract

The present invention belongs to the technical field of edible and medicinal compositions, and specifically relates to an edible and medicinal composition for assisting in regulating blood sugar, and its preparation method, application, and preparation. The edible and medicinal composition is composed of mulberry leaves, black sesame seeds, polygonatum, and yam. Animal experiments of the present invention show that only four edible and medicinal substances, namely mulberry leaves, black sesame seeds, polygonatum, and yam, as the edible and medicinal composition can have a good hypoglycemic effect. Compared with the prior art, the composition of the present invention has simple components, reasonable compatibility, low cost, small dosage, and fast short-term hypoglycemic effect. The edible and medicinal composition of the present invention not only has a significant effect on lowering blood sugar after meals, but also has a significant effect on improving complications such as dry mouth and thirst that are common in "Qi and Yin deficiency type" diabetes. Its raw materials are natural and harmless, highly safe, and the overall nature and taste are sweet and flat, making it suitable for long-term use.

Description

Technical Field

[0001] The present invention belongs to the technical field of medicine-food homologous compositions, and particularly relates to a medicine-food homologous composition for assisting in regulating blood sugar, a preparation method thereof, an application thereof, and a preparation thereof. Background Art

[0002] Diabetes is a chronic metabolic disorder characterized by hyperglycemia caused by various factors. The onset of diabetes is inevitably accompanied by an imbalance in blood sugar levels. When the pancreas secretes insulin into the blood, it triggers the conduction of insulin signal pathways, accelerating the body's uptake and utilization of glucose. After glucose is taken up by cells, it undergoes glycolysis or complete redox reactions to meet the body's energy needs or is synthesized into glycogen for later use. Any abnormality in any of these processes can lead to an imbalance in blood sugar levels and insulin resistance, causing diabetes. Diabetes, also known as "xiaoke disease" in Traditional Chinese Medicine, is most commonly diagnosed with Qi and Yin deficiency, characterized by dry mouth, thirst, and fatigue. Currently, there are many commercially available chemical drugs for the treatment of diabetes, such as insulin, metformin, sulfonylureas, and α-glucosidase inhibitors. Chemical drugs that lower blood sugar levels are targeted for diabetes control, quickly suppressing and alleviating symptoms, but they carry numerous side effects. Traditional Chinese medicines for diabetes, such as Morus alkaline tablets, require a 24-week course of treatment, are costly, and may cause side effects such as gastrointestinal irritation, such as bloating, diarrhea, and nausea. Traditional Chinese medicine compounds generally possess a higher concentration of pharmacologically active substances, lower potency, and less toxicity. They achieve their maximum efficacy through long-term accumulation, making them safer. They work through multiple components, targets, and pathways. Furthermore, many ingredients in traditional Chinese medicines have therapeutic properties. As of 2025, 110 Chinese medicinal materials have been approved by the government as food-drug ingredients. This means that these traditionally used ingredients are both foods and Chinese medicinal materials (food-drug ingredients) and can be developed into functional foods.

[0003] For example, the ancient classic recipe Sangma Pills comes from the Ming Dynasty medical book Shoushibaoyuan. The original recipe is called Fusang Zhibao Dan, which is made of mulberry leaves and black sesame seeds refined with honey. It is a medicine for prolonging life and is suitable for long-term use. It can make the body "smooth all over, revitalized, and free from diseases; walking and eyesight are strong; prolong life, replenish the marrow and add essence; and eliminate phlegm and produce body fluids." It is suitable for long-term health care and can be used clinically as a basic recipe for treating "Qi and Yin deficiency" type diabetes. However, the book does not specify the dosage of the drug.

[0004] For example, Chinese invention patent publication number CN108514093A discloses a multifunctional food composition for assisting in lowering blood sugar and a preparation method thereof. The food composition comprises the following components in parts by weight: 20-40 parts of yam, 10-30 parts of polygonatum, 2-20 parts of wolfberry, 2-20 parts of white poria, 1-5 parts of bitter melon, 1-5 parts of polygonatum, 1-5 parts of hawthorn, 1-5 parts of black sesame, 1-4 parts of mulberry leaves, 1-4 parts of dandelion, 1-2 parts of kudzu root, and 1-2 parts of platycodon. The food composition has the functions of assisting in lowering blood sugar, increasing insulin sensitivity, protecting the liver, and improving intestinal flora. However, the food composition of the invention is not only complex in ingredients and high in cost, but also requires continuous administration for 35 days, a long period of administration, and a slow effect on lowering blood sugar.

[0005] Another Chinese invention patent publication number CN113730506A discloses a Chinese medicine composition for lowering blood sugar and prolonging life and its preparation method, which is composed of the following raw materials in percentage by weight: Pueraria lobata, Salvia miltiorrhiza, buckwheat, Chinese yam, wolfberry, astragalus, ophiopogon japonicus, pumpkin seeds, mulberry leaves, American ginseng, polygonatum, and processed Polygonatum multiflorum. The kudzu root, salvia miltiorrhiza, and American ginseng are micropowders after wall-breaking and crushing, with a particle size of less than 10 μm-20 μm; the yam, wolfberry, polygonatum, and processed polygonum multiflorum are powders obtained by subjecting the crushed materials to a hypoglycemic treatment; the mulberry leaf refers to a powder obtained by mixing a mulberry leaf extract concentrate with a coating agent and spray-drying. In this invention, kudzu root and salvia miltiorrhiza are used as the main medicines, and mulberry leaves and buckwheat are used as the auxiliary medicines. Pumpkin seeds contain cucurbitine, vitamin B1, and vitamins, and have a good therapeutic effect in regulating carbohydrate metabolism. They are supplemented with processed polygonum multiflorum, astragalus, and ophiopogon, which can replenish the middle qi, strengthen the spleen and stomach, and enhance yang and strengthen the foundation. Polygonatum, American ginseng, yam, and wolfberry rich in amino acids are used as adjuvants. However, the raw materials of this traditional Chinese medicine composition are as many as 12 kinds, and they need to be consumed for 1-3 months. Long-term use can easily damage the liver and produce side effects. In addition, the preparation method is complicated, including hypoglycemic treatment, ultrafine grinding, and spray drying, making industrial production difficult.

[0006] Therefore, it is very important to provide a composition based on the principle of Chinese medicine compatibility and using medicinal and edible substances as raw materials, which has simple components, high safety, low cost, and can be used to assist in regulating blood sugar and take a quick effect in the short term, and has obvious therapeutic effects on "Qi and Yin deficiency type" diabetes. Summary of the Invention

[0007] In view of the problems existing in the prior art, the present invention provides a medicine-food composition for assisting in regulating blood sugar, as well as a preparation method, application and preparation thereof.

[0008] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] A medicine-food composition for assisting in regulating blood sugar, the medicine-food composition consisting of mulberry leaves, black sesame, polygonatum and yam.

[0010] Preferably, the edible-medicinal composition is composed of 10-14 parts of mulberry leaves, 2-4 parts of black sesame seeds, 3-6 parts of polygonatum and 1-3 parts of yam, calculated by weight.

[0011] More preferably, the edible and medicinal composition consists of 11-13 parts of mulberry leaves, 3-4 parts of black sesame seeds, 3-5 parts of polygonatum and 1.5-3 parts of yam, calculated by weight.

[0012] Further preferably, the medicine-food composition is composed of 12 parts of mulberry leaves, 4 parts of black sesame seeds, 3 parts of polygonatum and 3 parts of yam in parts by weight.

[0013] The mechanism of the medicinal and edible composition of the present invention in assisting in regulating blood sugar:

[0014] Mulberry leaf, [Nature and Flavor]: Cold, sweet, bitter. [Meridian Entrance]: Enters the Liver and Lung meridians. [Functions and Indications]: Dispels wind-heat, clears the lungs and moistens dryness, clears the liver and improves eyesight. It is used for wind-heat colds, lung-heat-induced dry coughs, dizziness, headaches, and red and blurred vision. The bioactive substances in mulberry leaf, such as flavonoids, alkaloids, and polysaccharides, can lower blood sugar by inhibiting α-glucosidase, reducing pancreatic oxidative damage, maintaining β-cell function, enhancing hepatic glycogen synthesis, and influencing the insulin signaling pathway.

[0015] Black sesame seeds are sweet and neutral in nature. They enter the liver, kidney, and large intestine meridians. They nourish the liver and kidneys, improve essence and blood, and moisten the intestines. They are used to treat essence and blood deficiency, dizziness, tinnitus, premature graying of hair, hair loss after illness, and constipation caused by dry intestines.

[0016] Polygonatum odoratum (Yuzhu) [Nature and Flavor] Sweet, slightly cold. [Meridian Entrance] Enters the Lung and Stomach meridians. [Functions and Indications] Nourishes yin and moistens dryness, promotes fluid production and quenches thirst. It is used for lung and stomach yin damage, dryness-heat cough, dry throat and thirst, and internal heat-induced thirst. Modern research shows that Polygonatum odoratum polysaccharides can increase insulin sensitivity, improve insulin resistance, and regulate glucose and lipid metabolism.

[0017] Chinese Yam (Yam) [Nature and Flavor]: Sweet, neutral. [Meridian Entrance]: Enters the spleen, lung, and kidney meridians. [Functions and Indications]: Tonifies the spleen and stomach, promotes fluid production and benefits the lungs, and nourishes the kidneys and astringes semen. It is used for spleen deficiency, poor appetite, chronic diarrhea, wheezing and coughing due to lung deficiency, spermatorrhea due to kidney deficiency, leucorrhea, frequent urination, and thirst due to deficiency-heat. Modern research also shows that Chinese Yam polysaccharides have a significant blood sugar-lowering effect.

[0018] There has been no report on the combination of the above four substances, which are both medicinal and edible, in assisting in lowering blood sugar while also improving diabetic complications such as dry mouth and thirst.

[0019] In addition, in addition to referring to pharmacopoeias, ancient books, reported literature and other materials, the present invention also screened and enriched the active pharmaceutical ingredients and targets related to black sesame, mulberry leaves, yam and polygonatum in the formula through the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform TCMSP to support the rationality and comprehensiveness of the formula of the present invention.

[0020] The present invention also provides a preparation for assisting in regulating blood sugar, comprising the above-mentioned medicine-food composition.

[0021] The present invention also provides a method for preparing the above-mentioned medicine-food composition, comprising the following steps:

[0022] (1) First, crush and sieve mulberry leaves, black sesame seeds, polygonatum and yam, and mix them to obtain mixed powder;

[0023] (2) Add water to the mixed medicine, soak, decoct, filter, and collect the residue and filtrate;

[0024] (3) Finally, boil the residue with water, filter, combine the filtrate, and concentrate to obtain the product.

[0025] Preferably, the mesh size of the sieving in step (1) is 30-50 mesh.

[0026] Preferably, the mass volume ratio of the mixed powder to water in step (2) is 1 g:8 mL-12 mL, and the soaking time is 35-45 min.

[0027] Preferably, the mass volume ratio of the filter residue to water in step (3) is 1 g:4 mL-6 mL.

[0028] Preferably, the decocting temperatures in step (2) and step (3) are both 90° C.-100° C., and the decocting time is both 25 min-45 min.

[0029] Preferably, the density after the concentration in step (3) is 0.4 g / mL-0.6 g / mL.

[0030] The present invention also provides the use of the medicine-food composition prepared by the above preparation method in preparing products for regulating blood sugar levels.

[0031] Preferably, the dosage form of the product is a liquid preparation, paste, pill, powder or granule.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] (1) The present invention demonstrates through animal experiments that a medicinal and edible composition of only four ingredients—mulberry leaves, black sesame seeds, polygonatum, and yam—can effectively lower blood sugar. Compared with the prior art, the present invention's composition has simpler components, more rational compatibility, lower cost, requires a smaller dosage, and exhibits a rapid, short-term blood sugar-lowering effect.

[0034] (2) The medicinal and edible composition of the present invention has a significant therapeutic effect on "Qi and Yin deficiency type" diabetes. Its raw materials are natural and harmless, highly safe, suitable for long-term use, and the overall nature and taste are sweet and flat. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 The effects of the compositions prepared in Example 1, Comparative Example 1 and Comparative Example 2 on postprandial blood glucose levels.

[0036] Figure 2 The effects of the compositions prepared in Examples 2 to 3 and Comparative Examples 3 to 5 on postprandial blood glucose levels are shown.

[0037] Figure 3 To study the effect on blood sugar levels of diabetes mellitus with "Qi and Yin deficiency type".

[0038] Figure 4 To study the effect of water intake on diabetes mellitus of "Qi and Yin deficiency type".

[0039] Figure 5 To study the effect of dietary intake on diabetes mellitus of "Qi and Yin deficiency type".

[0040] Figure 6 This is a Venn diagram of the active ingredient targets of the edible-medicinal composition and the diabetes targets.

[0041] Figure 7 GO functional analysis of targets related to the treatment of diabetes with medicinal and edible compositions.

[0042] Figure 8 KEGG pathway analysis of targets related to the treatment of diabetes by medicinal and edible compositions.

[0043] Figure 1 and Figure 2 Compared with the control group, * express P <0.05, *** express P <0.001.

[0044] Figure 3 and Figure 4 Compared with the blank control group, *** express P <0.001; compared with the Example 1 group, # express P <0.05,## express P <0.01. DETAILED DESCRIPTION

[0045] It is worth noting that the raw materials used in the present invention are all common commercially available products.

[0046] Example 1

[0047] A medicine-food composition for assisting in regulating blood sugar, comprising 1200 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum and 300 g of yam.

[0048] The preparation method of the composition is as follows:

[0049] (1) First, grind mulberry leaves, black sesame seeds, polygonatum and yam through a 40-mesh sieve and mix to obtain mixed powder;

[0050] (2) Add water to the mixed powder (material-liquid ratio is 1 g:10 mL), soak for 40 min, boil at 100°C for 30 min, filter, and collect the residue and filtrate;

[0051] (3) Finally, add water to the filter residue (the material-liquid ratio is 1 g:5 mL), boil at 100°C for 30 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.5 g / mL.

[0052] Example 2

[0053] A medicine-food composition for assisting in regulating blood sugar, comprising 1200 g of mulberry leaves, 200 g of black sesame seeds, 300 g of polygonatum and 300 g of yam.

[0054] The preparation method of the composition is as follows:

[0055] (1) First, grind mulberry leaves, black sesame seeds, polygonatum and yam through a 30-mesh sieve and mix to obtain mixed powder;

[0056] (2) Add water to the mixed powder (material-liquid ratio is 1 g:8 mL), soak for 35 min, boil at 90°C for 45 min, filter, and collect the residue and filtrate;

[0057] (3) Finally, add water to the filter residue (the material-liquid ratio is 1 g:4 mL), boil at 90°C for 45 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.6 g / mL.

[0058] Example 3

[0059] A medicine-food composition for assisting in regulating blood sugar, comprising 1200 g of mulberry leaves, 400 g of black sesame seeds, 600 g of polygonatum and 150 g of yam.

[0060] The preparation method of the composition is as follows:

[0061] (1) First, grind mulberry leaves, black sesame seeds, polygonatum and yam through a 50-mesh sieve and mix to obtain mixed powder;

[0062] (2) Add water to the mixed powder (material-liquid ratio is 1 g:12 mL), soak for 45 min, boil at 100°C for 35 min, filter, and collect the residue and filtrate;

[0063] (3) Finally, add water to the filter residue (the material-liquid ratio is 1 g:6 mL), boil at 100°C for 35 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.4 g / mL.

[0064] Comparative Example 1

[0065] The only difference from Example 1 is that the components also contain wolfberry, as follows:

[0066] A medicine-food composition for assisting in regulating blood sugar, comprising 1200 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum, 300 g of yam, and 300 g of wolfberry.

[0067] (1) First, grind mulberry leaves, black sesame seeds, polygonatum, yam and wolfberry, pass through a 40-mesh sieve, and mix to obtain a mixed powder;

[0068] (2) Add water to the mixed powder (material-liquid ratio is 1 g:10 mL), soak for 40 min, boil at 100°C for 30 min, filter, and collect the residue and filtrate;

[0069] (3) Finally, add water to the filter residue (the material-liquid ratio is 1 g:5 mL), boil at 100°C for 30 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.5 g / mL.

[0070] Comparative Example 2

[0071] The only difference from Example 1 is that the component also contains Polygonatum sibiricum, which is as follows:

[0072] A medicine-food composition for assisting in regulating blood sugar, comprising 1200 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum, 300 g of yam, and 300 g of polygonatum.

[0073] The preparation method of the composition is as follows:

[0074] (1) First, grind mulberry leaves, black sesame, polygonatum, yam and polygonatum through a 40-mesh sieve and mix to obtain a mixed powder;

[0075] (2) Add water to the mixed powder (material-liquid ratio is 1 g:10 mL), soak for 40 min, boil at 100°C for 30 min, filter, and collect the residue and filtrate;

[0076] (3) Finally, add water to the filter residue (the material-liquid ratio is 1 g:5 mL), boil at 100°C for 30 min, combine the two filtrates, and concentrate to obtain a concentrated solution with a density of 0.5 g / mL.

[0077] Comparative Example 3

[0078] The only difference from Example 1 is the different composition ratios, which are as follows:

[0079] A medicine-food composition for assisting in regulating blood sugar, comprising 300 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum and 300 g of yam.

[0080] The preparation method of the composition is the same as that of Example 1.

[0081] Comparative Example 4

[0082] The only difference from Example 1 is the different composition ratios, which are as follows:

[0083] A medicine-food composition for assisting in regulating blood sugar, comprising 1200 g of mulberry leaves, 2000 g of black sesame seeds, 300 g of polygonatum and 300 g of yam.

[0084] The preparation method of the composition is the same as that of Example 1.

[0085] Comparative Example 5

[0086] The only difference from Example 1 is the different composition ratios, which are as follows:

[0087] A medicine-food composition for assisting in regulating blood sugar, comprising 1200 g of mulberry leaves, 400 g of black sesame seeds, 300 g of polygonatum and 2000 g of yam.

[0088] The preparation method of the composition is the same as that of Example 1.

[0089] Test Example 1

[0090] Postprandial hypoglycemic evaluation experiments were conducted on the edible and medicinal compositions for assisting blood sugar regulation prepared in Example 1, Comparative Example 1, and Comparative Example 2, respectively. The specific experimental methods are as follows:

[0091] 1. Experimental Materials

[0092] 1.1 Research object: the medicinal and edible compositions prepared in Example 1, Comparative Example 1 and Comparative Example 2.

[0093] 1.2 Experimental animals: 24 SPF-grade male ICR mice, 3 weeks old, weighing 15 g–20 g, were purchased from Beijing Weitonglihua Laboratory Animal Technology Co., Ltd., with the experimental animal production license number: SCXK (Beijing) 2021-0006.

[0094] 2. Experimental Methods

[0095] ICR mice were given free access to water and fasted for 12 hours before being randomly divided into four groups, each consisting of six mice: a control group, Example 1, Comparative Example 1, and Comparative Example 2. The oral dose for Example 1, Comparative Example 1, and Comparative Example 2 was 2.86 g / kg; the control group received an equal volume of distilled water. Half an hour later, each group was gavaged with 3 g / kg of sucrose. Blood glucose levels were measured using a glucometer 30, 60, and 120 minutes after the final gavage. The AUC values ​​were calculated using GraphPad Prism 8 software to assess the effect of the composition on total blood glucose.

[0096] Description: The area under the blood glucose curve (AUC) is an indicator used to assess blood glucose control. It measures the area under the blood glucose curve over a specific period of time to reflect overall blood glucose fluctuations. Larger AUC values ​​indicate greater blood glucose fluctuations and poorer control; smaller AUC values ​​indicate less blood glucose fluctuations and better control. Therefore, the AUC value, as an important indicator for assessing blood glucose control, is crucial for the management and treatment of diabetic patients.

[0097] 3. Statistical methods

[0098] The statistical differences among the groups were compared using one-way analysis of variance. P <0.05 indicated that the difference was statistically significant.

[0099] 4. Data Analysis

[0100] The experimental results are shown in Table 1 and Figure 1 As shown, compared with the control group, the 30-min blood glucose level, 60-min blood glucose level and AUC value of the mice in Example 1 were significantly reduced ( P <0.05 or P <0.001), indicating that Example 1 has a significant hypoglycemic effect.

[0101] Compared with the control group, although the blood glucose value of Comparative Example 1 at 30 min was significantly lower than that of the control group, it did not reach the blood glucose peak. It still showed a slow upward trend from 30 min to 60 min, especially the blood glucose value at 60 min was even slightly higher than that of the control group. Combined with the fact that its AUC value did not decrease significantly, it showed that the comparative example could delay blood glucose absorption, but had no significant effect on lowering the total blood glucose. In addition, from the perspective of total blood glucose, the AUC value of Comparative Example 1 was significantly higher than that of Example 1, indicating that its overall blood glucose-lowering effect was weaker than that of Example 1. There was no significant difference in the blood glucose peak and AUC values ​​of Comparative Example 2, and the AUC value was significantly higher than that of Example 1.

[0102] The above experimental results show that only the specific medicine-food composition of the present invention has a significant blood sugar-lowering effect on both postprandial blood sugar value and total blood sugar. It has simple components, low cost, small dosage and fast blood sugar-lowering effect.

[0103] Table 1 Effects of the compositions prepared in Example 1, Comparative Example 1 and Comparative Example 2 on postprandial blood glucose levels and total blood glucose levels

[0104]

[0105] Note: Compared with the blood glucose level of the control group at the same time point, * express P <0.05, *** express P <0.001; the same letters in a and b indicate no significant difference in AUC values; different letters indicate a significant difference in AUC values.

[0106] Test Example 2

[0107] Postprandial hypoglycemic evaluation experiments were conducted on the edible and medicinal compositions for assisting in regulating blood sugar prepared in Examples 2 to 3 and Comparative Examples 3 to 5, respectively. The specific experimental methods are as follows:

[0108] 1. Experimental Materials

[0109] 1.1 Research object: the medicinal and edible compositions prepared in Examples 2-3 and Comparative Examples 3-5.

[0110] 1.2 Experimental animals: 30 SPF-grade male ICR mice, 3 weeks old, weighing 15 g–20 g, were purchased from Beijing Weitonglihua Laboratory Animal Technology Co., Ltd., with the experimental animal production license number SCXK (Beijing) 2021-0006.

[0111] 2. Experimental Methods

[0112] ICR mice were given free access to water and fasted for 12 hours before being randomly divided into six groups, each consisting of five mice: the control group, Example 2-Example 3 groups, and Comparative Example 3-Comparative Example 5 groups. The oral gavage dose for Example 2-Example 3 and Comparative Example 3-Comparative Example 5 groups was 2.86 g / kg; the control group received an equal volume of distilled water. Half an hour later, each group was gavaged with 3 g / kg of sucrose. Blood glucose levels were measured using a glucometer 30, 60, and 120 minutes after the last gavage. The AUC value was calculated using GraphPad Prism 8.0 software to evaluate the effect of the composition on total blood glucose.

[0113] 3. Statistical methods

[0114] The statistical differences among the groups were compared using one-way analysis of variance. P <0.05 indicated that the difference was statistically significant.

[0115] 4. Data Analysis

[0116] The experimental results are shown in Table 2 and Figure 2 As shown, compared with the control group, the blood glucose levels and AUC of the mice in Example 2 and Example 3 were significantly reduced ( P <0.05), indicating that both examples have significant hypoglycemic effects. Compared with the control group, although the area under the blood glucose curve (AUC) values ​​of the mice in Comparative Examples 3 and 4 were significantly reduced, there was no significant difference in peak blood glucose levels. There was no significant difference in either peak blood glucose levels or AUC values ​​of the mice in Comparative Example 5, indicating that only the medicinal and edible composition with the specific ratio of the present invention has a significant hypoglycemic effect in terms of both peak blood glucose and total blood glucose.

[0117] Table 2 Effects of the composition of the present invention on blood sugar level and total blood sugar

[0118]

[0119] Note: Compared with the blood glucose level of the control group at the same time point, * express P <0.05; compared with the AUC value of the control group, # express P <0.05.

[0120] Test Example 3

[0121] The therapeutic effect of the medicine-food composition for assisting blood sugar regulation prepared in Example 1 on diabetes was tested. The specific experimental method is as follows:

[0122] 1. Experimental Materials

[0123] 1.1 Research subjects: the medicinal and edible composition and mulberry leaf concentrate prepared in Example 1.

[0124] The preparation method of mulberry leaf concentrate is as follows: weigh 81 g of mulberry leaves, add 3000 mL of pure water, soak for 40 min, boil for 30 min, filter, add 3000 mL of water to the residue and boil again for 30 min, combine the two decoctions and concentrate to prepare a mulberry leaf concentrate with a concentration of 0.27 g / mL, and set aside.

[0125] 1.2 Experimental animals: 32 Wistar rats were purchased from Beijing Weitonglihua Laboratory Animal Technology Co., Ltd., with the experimental animal production license number: SCXK (Beijing) 2021-0006.

[0126] 2. Animal Model Construction

[0127] Wistar rats were first observed for one week of adaptive feeding and then fed a high-fat diet for two weeks. After an overnight fast with no water deprivation for 1120 min, streptozotocin (STZ) 35 mg / kg was injected intraperitoneally (STZ was freshly prepared in a citric acid-sodium citrate buffer solution with a pH of 4.5 and a concentration of 0.1 mol / L in a 4°C ice bath). One week after STZ injection, blood was collected from the tail vein of the rats to measure fasting blood glucose (fasted for 16 h) and glucose tolerance. Rats with fasting blood glucose >11.1 mmol / L and glucose area under the curve (AUC) >30 were selected as the "Qi and Yin deficiency type" diabetes model.

[0128] 3. Animal Grouping and Dosing

[0129] Wistar rats were randomly divided into four groups, 8 rats in each, including a blank control group, a model group, the Example 1 group, and a mulberry leaf group. All rats in the blank control group were modeled with type 2 diabetes mellitus (Qi and Yin deficiency). After modeling, rats in the Example 1 and mulberry leaf groups were given the corresponding concentrates at a gavage dose of 10 mL / kg twice daily for 6 weeks. The blank control and model groups were given the same volume of distilled water. Blood glucose levels (mmol·L) were measured weekly by fasting for 4 hours and then sampling from the rats' tail vein. -1 The mean AUC values ​​were calculated using GraphPad Prism 8 software.

[0130] 4. Statistical methods

[0131] The statistical differences among the groups were compared using one-way analysis of variance. P <0.05 indicated that the difference was statistically significant.

[0132] 5. Data Analysis

[0133] 5.1 Effect on blood sugar level: Figure 3As shown in Figure 2, at week 6, the blood glucose levels of the rats in the model group were significantly higher than those in the blank control group ( P <0.001), indicating that the "Qi Yin Deficiency Type" diabetes model was successfully established; compared with the Example 1 group, the blood glucose levels of the model group and the mulberry leaf group were significantly higher than those of the Example 1 group ( P <0.05), indicating that the edible and medicinal composition of Example 1 has significant hypoglycemic activity, and is stronger than mulberry leaf. Furthermore, the blood glucose level in the mulberry leaf group was higher than that in the model group, with no significant difference between the two groups, indicating that mulberry leaf has no significant hypoglycemic activity. These results indicate that for "Qi and Yin deficiency" type diabetes, long-term use of mulberry leaf alone has no hypoglycemic effect, while the edible and medicinal composition of the present invention has the efficacy of significantly lowering blood glucose in diabetic patients.

[0134] 5.2 Impact on water intake: Figure 4 As shown in Figure 2, at week 6, the water intake of rats in the model group was significantly higher than that in the blank control group ( P <0.001), indicating that the "Qi and Yin deficiency type" diabetes model will have dry mouth and polydipsia; compared with the Example 1 group, the water intake of the model group and the mulberry leaf group was significantly higher than that of the Example 1 group ( P <0.01), indicating that the edible and medicinal composition of Example 1 has a significant effect on improving dry mouth and can basically restore water intake to normal levels. In addition, the mulberry leaf group drank more water than the model group, and there was no significant difference between the two groups, indicating that mulberry leaf has no effect on improving dry mouth and polydipsia in diabetic patients. These results show that for "Qi and Yin deficiency" type diabetes, long-term use of mulberry leaf alone has no effect on improving diabetic dry mouth and polydipsia, while the edible and medicinal composition of the present invention has a significant effect on improving dry mouth and polydipsia in diabetic patients.

[0135] 5.3 Effect on food intake: Figure 5 As shown, at the 4th week, the food intake of rats in Example 1 group was slightly lower than that in the model group and the mulberry leaf group, which has the potential effect of improving the "excessive eating" symptom.

[0136] Test Example 4

[0137] Bioinformatics methods were used to screen and enrich the active ingredients and targets in the edible and medicinal composition of the present invention to further verify the rationality of the formulation of the composition of the present invention. The steps are as follows:

[0138] 1. The Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP https: / / old.tcmsp-e.com / tcmspsearch.php) was used to search for the edible and medicinal components of the present invention, including black sesame, mulberry leaves, Chinese yam, and polygonatum. Oral bioavailability (OB) ≥ 30% and drug likeness (DL) ≥ 0.18 were set. Combined with Lipinski's five principles (Mw ≤ 500, miLogP ≤ 5, nOHNH ≤ 5, nOH ≤ 10) as screening conditions, the active pharmaceutical ingredients and targets related to the edible and medicinal compositions were searched.

[0139] Screening the TCMSP database revealed five active ingredients from black sesame, 18 from mulberry leaf, nine from Chinese yam, and eight from Polygonatum odoratum. See Tables 3-6 for their information. A total of 572 potential targets were identified for the 40 active ingredients using the Pubchem and TCMSP databases, and processed using the SwissTargetPrediction and Uniprot databases.

[0140] Table 3 Active ingredients of black sesame

[0141]

[0142] Table 4 Active ingredients of mulberry leaves

[0143]

[0144] Table 5 Active ingredients of yam

[0145]

[0146] Table 6 Active ingredients of Polygonatum odoratum

[0147]

[0148] 2. The Pubchem database (https: / / pubchem.ncbi.nlm.nih.gov) was used to search for canonical SMILES of food-drug homologous components. The targets of food-drug homologous components were predicted using SwissTargetPrediction (http: / / www.swisstargetprediction.ch), and targets with a probability greater than 0 were screened. The protein targets corresponding to the active ingredients of food-drug homologous components were searched using the TCMSP database (https: / / old.tcmsp-e.com / tcmsp.php). The key chemical component information screened in the TCMSP database was converted into target proteins using the Uniprot database (https: / / www.uniprot.org). Non-human target proteins were eliminated, and the targets of the two databases were combined to finally determine the targets corresponding to the food-drug homologous components.

[0149] 3. Using diabetes mellitus as the keyword, in DisGeNET ( https: / / www.disgenet.org ) database and GeneCards ( https: / / www.genecards.org ) database to search for potential disease targets. Targets from both databases were integrated and duplicate targets were removed to obtain potential targets for diabetes.

[0150] There are 1455 related targets in the DisGeNET database and 1829 related targets in the Gene Cards database. After merging the targets of the two disease databases and removing duplicates, 2476 targets related to diabetes were obtained.

[0151] 4. Using Venny 2.1.0 ( https: / / bioinfogp.cnb.csic.es / tools / venny ) The chemical component targets obtained by screening were intersected with the disease targets to obtain 257 potential targets for the treatment of diabetes by medicinal and edible compositions, see Figure 6 .

[0152] 5. Using Cytoscape 3.10.1 software, the active ingredient-target network of the edible and medicinal composition was constructed and visualized. The network contains 587 nodes and 1660 edges.

[0153] A network of active ingredients of edible and medicinal compositions-common targets-diabetes was constructed, and it was found that there were 296 nodes in total, 37 active ingredients of edible and medicinal compositions for treating diabetes, 257 targets that synergistically acted on diabetes, and 1,132 edges, i.e., the interaction relationships between nodes.

[0154] 6. By inputting the medicinal and edible compositions and common targets of diabetes into the String database (https: / / string-db.org), the PPI network diagram was obtained with a correlation r>0.400 as the cutoff value, and the interaction network diagram of the medicinal and edible compositions and diabetes was derived.

[0155] 7. Import the intersection genes into the DAVID database ( https: / / david.ncifcrf.gov ), GO and KEGG enrichment analysis was performed on the intersection targets.

[0156] GO analysis took the first 10 genes for visualization and constructed a histogram with the help of the microbial information platform. The results are shown in Figure 7 GO functional enrichment analysis of key genes in TCM compound-related diabetes mellitus in the DAVID database revealed 798 biological process pathways, 97 cellular component pathways, and 172 molecular function pathways. The top 10 pathways were ranked by number of enriched genes, and a bar chart was plotted. GO functional enrichment analysis revealed that these genes primarily act on diabetes through pathways such as signal transduction, plasma membrane, and protein binding.

[0157] KEGG analysis was performed, and the top 20 significant signal pathways with the highest P value were selected for visualization. Bubble charts were constructed using the Microbiome Information Platform. The results are shown in the figure. Figure 8 The results of KEGG pathway enrichment analysis showed that key genes were mainly enriched in pathways such as cancer pathways, HF-1 signaling pathway, and PI3K-Akt signaling pathway.

[0158] From the perspective of big data bioinformatics analysis, the rationality and comprehensiveness of the formula of the present invention and its potential to assist in lowering blood sugar are fully demonstrated.

[0159] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A medicine-food composition for assisting in regulating blood sugar, characterized in that: The medicine-food composition consists of 10-14 parts of mulberry leaves, 2-4 parts of black sesame seeds, 3-6 parts of polygonatum and 1-3 parts of yam in parts by weight.

2. The medicine-food composition according to claim 1, characterized in that The medicine-food composition consists of 11-13 parts of mulberry leaves, 3-4 parts of black sesame seeds, 3-5 parts of polygonatum and 1.5-3 parts of yam in parts by weight.

3. A preparation for assisting in regulating blood sugar, characterized in that: The invention comprises the medicine-food composition according to claim 1 or 2 and pharmaceutically acceptable excipients.

4. A method for preparing the medicine-food composition according to claim 1 or 2, characterized in that: The steps include: (1) First, crush and sieve mulberry leaves, black sesame seeds, polygonatum and yam, and mix them to obtain mixed powder; (2) Add water to the mixed powder, soak, boil, filter, and collect the residue and filtrate; (3) Finally, boil the residue with water, filter, combine the filtrate, and concentrate to obtain the product.

5. The preparation method according to claim 4, characterized in that The mesh size of the sieving in step (1) is 30-50 mesh; the mass volume ratio of the mixed powder to water in step (2) is 1 g:8 mL-12 mL, and the soaking time is 35 min-45 min; the mass volume ratio of the filter residue to water in step (3) is 1 g:4 mL-6 mL.

6. The preparation method according to claim 4, characterized in that The decoction temperatures in step (2) and step (3) are both 90° C.-100° C., and the decoction times are both 25 min-45 min.

7. The preparation method according to claim 4, characterized in that The density after the concentration in step (3) is 0.4 g / mL-0.6 g / mL.

8. Use of the medicine-food composition prepared by the preparation method according to any one of claims 4 to 7 in preparing a product for regulating blood sugar levels.

9. The use according to claim 8, characterized in that The dosage form of the product is liquid preparation, ointment, pill, powder or granule.

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